Korean Patent PracticeKorean Patent Practice- Pharmaceutical field -- Pharmaceutical field -

Jonghyeok ParkJonghyeok Park MS., Ph.D.courseMS., Ph.D.coursePartnerPharmacistPatent Attorney

Y. S. CHANG & ASSOCIATESY. S. CHANG & ASSOCIATESMay 2009May 2009

Mr. Jong-Hyeok ParkPartner, Pharmacist, Patent Attorney- B.S., Pharmacy- M.S., Pharmacy- Ph.D. Course, Pharmacy

PresenterPresenter

ContentsContentsⅠ Ⅰ Basic InformationBasic Information

ⅰ ⅰ Patentable Subject MattersPatentable Subject Matters

ⅱ ⅱ Claim DescriptionClaim Description

ⅲ ⅲ Support requirementSupport requirement

(Pharmacological data)(Pharmacological data)

Ⅱ Ⅱ PTE applicationPTE applicationⅰ ⅰ Outline of the PTE systemOutline of the PTE system

ⅱ ⅱ Extension periodExtension period

ⅲ ⅲ ProblemsProblems

Ⅲ Ⅲ Issues regarding FTAIssues regarding FTAⅰ ⅰ Patent-approval linkagePatent-approval linkage

ⅱ ⅱ Data exclusivityData exclusivity

ⅲ ⅲ Patent Term ExtensionPatent Term Extension

ⅳ ⅳ Bolar exceptionBolar exception

ⅣⅣ Litigation - Case studiesLitigation - Case studies

ⅰ ⅰ PLAVIXPLAVIX®® (clopidogrel bisulfate) (clopidogrel bisulfate)

ⅱ ⅱ NORVASCNORVASC®® (amlodipine (amlodipine besylate)besylate)

ⅲ ⅲ Lipitor Lipitor ®®(atorvastatin)(atorvastatin)

ⅳ ⅳ ULTRACETULTRACET®® (tramadol/AAP) (tramadol/AAP)

Patentable Subject Patentable Subject MattersMatters

Surgical and diagnostic methods practiced on the human Surgical and diagnostic methods practiced on the human are not allowedare not allowed– A method of surgeryA method of surgery– Treating method of a human beings including DNA therapyTreating method of a human beings including DNA therapy

– Method of diagnosis for human beingsMethod of diagnosis for human beings

ExceptionException– Medical treatment is allowed if a human beings is expressly excludedMedical treatment is allowed if a human beings is expressly excluded

Diagnosis method may be patentable if claimDiagnosis method may be patentable if claim– does not contain the clinical decision step(i.e., deductive decision does not contain the clinical decision step(i.e., deductive decision

phase).phase).

– does not contain the surgical step which is practiced on human in order does not contain the surgical step which is practiced on human in order to collect datato collect data

New System(From 2008)

Claim DescriptionClaim Description ““Use of compound for the use of treating ~Use of compound for the use of treating ~”” claim is not claim is not

allowedallowed– Instead, Instead, ““Pharmaceutical composition comprising the compound for Pharmaceutical composition comprising the compound for

treating ~treating ~”” should be used. should be used.

Medical use of a pharmaceutical composition must be recited Medical use of a pharmaceutical composition must be recited in claims when claiming a pharmaceutical compositionin claims when claiming a pharmaceutical composition– Medical use should be specified by the specific diseases, e.g., treating Medical use should be specified by the specific diseases, e.g., treating

pulmonary cancer, etc.pulmonary cancer, etc.

– No functional expression, no reach through claim can be used in claims No functional expression, no reach through claim can be used in claims when specifying the medical use.when specifying the medical use.

– Contrary to the KIPOContrary to the KIPO’’s guideline, s guideline, ““angiogenesis inhibitorangiogenesis inhibitor”” has been has been exceptionally allowed by Supreme Court, but not normal practice.exceptionally allowed by Supreme Court, but not normal practice.

Support RequirementSupport Requirement(Data Requirement)(Data Requirement)

Specific pharmacological data are strictly requiredSpecific pharmacological data are strictly required– Actual data such as ICActual data such as IC5050 values of individual compounds should be values of individual compounds should be

contained in originally filed specificationcontained in originally filed specification

– Simple description on pharmacological activity is not sufficientSimple description on pharmacological activity is not sufficient

– Reasonable correlation between the pharmacological activity and Reasonable correlation between the pharmacological activity and the claimed medical use should be substantiated by data described the claimed medical use should be substantiated by data described in specificationin specification

Later submission of data is not allowedLater submission of data is not allowed– Before 2000, supreme court allowed the applicant to submit such Before 2000, supreme court allowed the applicant to submit such

data during prosecutiondata during prosecution

Outline of the PTE systemOutline of the PTE system Type of Inventions eligible for Type of Inventions eligible for

PTEPTE– only permitted for inventions

pertaining to pharmaceutical products and agricultural chemicals

– Cosmetics, food additives, Cosmetics, food additives, pigments, and medical pigments, and medical instruments may not be instruments may not be entitled to PTEentitled to PTE

Deadline for filing PTEDeadline for filing PTE– Within 3 months from the Within 3 months from the

approval date except for the approval date except for the last six months from the expiry last six months from the expiry date of the original patent termdate of the original patent term

Number of times of PTENumber of times of PTE– One(1) extension is allowed One(1) extension is allowed

per one patentper one patent– A divisional application should A divisional application should

be preferably filed during be preferably filed during examination stage if two or examination stage if two or more approval can be more approval can be obtainedobtained

– If three patents for one If three patents for one approval, each of the patents approval, each of the patents is entitled to PTEis entitled to PTE

Maximum amount of time that Maximum amount of time that the patent can be extended the patent can be extended – 5 years5 years

Restoration PeriodRestoration Period Calculated from the sum of “Period required to conduct clinical

trial” and “period required to conduct regulatory review”

Can be reduced when the applicant fails to act with due

diligence

ProblemsProblems Period required to

conduct clinical trial in foreign country is not added to the restoration period.

Restoration periods which global pharmaceutical companies has actually obtained are not that long, a few months.

US-Bahrain FTA 15.9(6)

Patent LinkagePatent Linkage US requests Korean government to introduce

patent linkage, but in progress– Generic companies have to inform HIRA on when they will begin to

sell the generic drugs, in case there is patent right covering the drug.

– If an innovator company raises a legal measure against generic companies, 12 months stay will be obtained

Points at issue– Whether of not a confirmation trial should be included in the legal

measure

– Whether of not 12 months stay should be appropriate, too short?, too long?

Data exclusivityData exclusivity There is no explicit provision regarding data exclusivity

in Korean pharmaceutical affair act However, as a practical matter, the KFDA has a

reexamination system based on data exclusivity by which a pharmaceutical company that first obtains regulatory approval, can block a second company from obtaining a second, subsequent approval, for a certain product for a given period– 6 years for new drugs

– 4 years for drugs having new medical use

Patent Term ExtensionPatent Term Extension No issue

– Korea has already PTE system which can meet US’s request

Clinical Trial conducted in Foreign countries

– Maybe not easy

Bolar ExceptionBolar Exception Article 96 (Limitations on Patent Right)

– (1) The effects of the patent right shall not extend to the following: » Working of the patented invention for the purpose of research or

experiment;» Vessels, aircraft or vehicles merely passing through the Republic of

Korea or machinery, instruments, equipment or other accessories used therein; or

» Articles existing in the Republic of Korea at the time the patent application was filed.

Therefore, generics manufacturers are allowed to manufacture the patented drug for the purpose of obtaining marketing approval before the patent protection expires.

– Storage after obtaining approval does not constitute patent infringement(Patent Court, now pending before supreme court)

PLAVIXPLAVIX®® (clopidogrel bisulfate) (clopidogrel bisulfate)

Blood Clot inhibitor Patent has been

invalidated due to lack of an inventive step by PatentCourt

– Enatiomer : selection invention– No unexpected effect is

achieved by adapting one enantiomer from racemate

Point at issue– Of opinion that it does have an

unexpected effect by adapting the salt of “bisulfate”

– Now, pending before supreme court

Sanofi-Aventis vs.17 Korean generic manufacturers

NORVASCNORVASC®® (amlodipine besylate) (amlodipine besylate)

LEVOTENSION (S-amlodipine besylate dihyrate)

– Falls within the scope of the patent right relating NORVASC® (amlodipine besylate) because S-amlodipine besylate dihyrate is only one specific embodiments of amlodipine besylate.

– Patent right relating a compound can cover both anhydride and hydrate thereof

But, later, this patent has been invalidated, same as United States

Pfizer Inc. vs. Ahn-Gook Pharm. Co.,Ltd.

ULTRACETULTRACET®® (tramadol/AAP) (tramadol/AAP)

Patent covering Ultracet duly exists.

– A generic manufacture has filed an invalidation trial against the patent.– More than 100 generic companies have applied for marketing approval for generic version of Ultracet®® and obtained marketing approval. – Now many kinds of generic version of Ultracet®® are being sold.– Waiting for the 1st instance decision

If they are not successful in the invalidation trial, then?

Ortho-McNeil-Janssen Pharmaceuticals vs.15 Korean generic manufacturers

Any Questions?Any Questions?

Thank you very muchThank you very much